FDA 510(k) clearances — page 1354

176,637 clearances on record, most recent first.

Clearances — page 1354

135,301–135,400 of 176,637

K883031 — Q-CATH RMQuinton, Inc.·Product code DXJ·1988-09-20
K883121 — QUIK-PACE II ELECTRODESPhysio-Control Corp.·Product code DRO·1988-09-20
K875179 — MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403ATsi, Inc.·Product code DPW·1988-09-19
K880360 — MODEL #1551 SWITCH CONTROL INTERFACE UNITInvacare Corp.·Product code ITI·1988-09-19
K880361 — MODEL #1552 ATTENDANT CONTROL OPTIONInvacare Corp.·Product code ITI·1988-09-19
K880362 — MODEL #1553 RECLINER INTERFACEInvacare Corp.·Product code ITI·1988-09-19
K880363 — MODEL #1554 PNEUMATIC SWITCHInvacare Corp.·Product code ITI·1988-09-19
K880364 — MODEL #1555 REMOTE JOYSTICKInvacare Corp.·Product code ITI·1988-09-19
K880365 — MODEL #1556 HEAVY-DUTY JOYSTICKInvacare Corp.·Product code ITI·1988-09-19
K880426 — ELECTROSTIMULATOR MODEL 808Cornell Enterprises Co., Inc.·Product code GZJ·1988-09-19
K881993 — PXI (PERSONAL X-RAY IMAGER) 512Oklahoma Digital Technologies, Inc.·Product code LLZ·1988-09-19
K882133 — MAMMO MZiehm International, Inc.·Product code IZH·1988-09-19
K882326 — VARIAN CLINAC 1800SVarian Assoc., Inc.·Product code IYE·1988-09-19
K882663 — BARBITURATE ENZYME IMMUNOASSAY KITGeneral Diagnostics·Product code DIS·1988-09-19
K882729 — MEVATRON, M 2 CLASSSiemens Medical Laboratories, Inc.·Product code IYE·1988-09-19
K882891 — A.C.I. TRACH TIEAuxiliary Care, Inc.·Product code CBH·1988-09-19
K883181 — SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGEBeckman Instruments, Inc.·Product code CKA·1988-09-19
K883210 — EMIT (R) HVA NEGATIVE URINESyva Co.·Product code DIF·1988-09-19
K883395 — ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZYQuantimetrix Medical Industries·Product code JJT·1988-09-19
K883463 — HOSPITAL BED CLOTHING CRADLECommercial Products & Engineering Co.·Product code FNL·1988-09-19
K883503 — COULTER VISCOMETER IICoulter Electronics, Inc.·Product code JJL·1988-09-19
K883702 — EXCELVIEW ILLUMINATORExcel Medical Products, Inc.·Product code IXC·1988-09-19
K881297 — BARO-GRAF 24Instromedix, Inc.·Product code DRS·1988-09-16
K882655 — PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINEProcedure Packs, Inc.·Product code DQO·1988-09-16
K882664 — MRL OXIMETERMedical Research Laboratories, Inc.·Product code DQA·1988-09-16
K882716 — PROCEDURE PACKS SOLUTION ADMINISTRATION SETSProcedure Packs, Inc.·Product code DQD·1988-09-16
K882720 — SCIMED R30 SILICONE ASSIST RESERVOIRScimed Life Systems, Inc.·Product code DTN·1988-09-16
K882803 — ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE STAdvanced Cardiovascular Systems, Inc.·Product code DQY·1988-09-16
K883016 — POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIPCardiac Control Systems, Inc.·Product code DTB·1988-09-16
K883086 — INTERSEPT*PREBYPASS FILTERMedtronic Blood Systems, Inc.·Product code KRJ·1988-09-16
K883325 — PERFORMED CROWN (STAINLESS STEEL)Whitecap Dental Co.·Product code ELZ·1988-09-16
K883558 — VITEK GRAM-NEGATIVE IDENTIFICATION CARDVitek Systems, Inc.·Product code JSS·1988-09-16
K883650 — INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110Instrumentarium Corp.·Product code LNH·1988-09-16
K883682 — CHANG MEDIUM (ADDITIONAL INDICATIONS)Hana Biologics, Inc.·Product code KIT·1988-09-16
K881811 — COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERSCobe Laboratories, Inc.·Product code FJI·1988-09-15
K881889 — CANON IOL ESTIMATOR KU-1Canon USA, Inc.·Product code IYO·1988-09-15
K882556 — BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI.Bd Becton Dickinson Vacutainer Systems Preanalytic·Product code FRN·1988-09-15
K882605 — EURO-MED CLEAR-VUE DISPOSABLE VAGINAL SPECULUMBuckman Co., Inc.·Product code HIB·1988-09-15
K882721 — ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EARHear-O Inc. C/O L.P. Leale & Assoc.·Product code ESD·1988-09-15
K882821 — VITRABOND LIGHT CURE GLASS IONOMER LINER3M Company·Product code EKJ·1988-09-15
K883099 — SITE MACROBORE PHACO NEEDLESite Microsurgical Systems, Inc.·Product code HQC·1988-09-15
K883199 — MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEMChiron Vision Corp.·Product code HQC·1988-09-15
K883213 — NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)Nidek, Inc.·Product code HQF·1988-09-15
K883255 — KOMET SURGICAL BURKomet Medical, Div. of Brasseler USA I, L.P.·Product code GFF·1988-09-15
K883311 — COUNT-A-DOSEPavel Jordan & Associates, Inc.·Product code FMF·1988-09-15
K883507 — HERAEUS C SPECIALDegussa Dental, Inc.·Product code EJS·1988-09-15
K883510 — DEGUPAL 4Degussa Dental, Inc.·Product code EJS·1988-09-15
K883613 — OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO.Stierlen-Maquet AG·Product code GDC·1988-09-15
K883614 — CYTOGUARD(R)Survival Technology, Inc.·Product code FMF·1988-09-15
K883657 — SKID RESISTANT, LONG LASTING SHOE COVERSJames River Corp.·Product code FXP·1988-09-15
K883771 — SUNGLASSES, IMPORTEDNorcon, Inc.·Product code HQY·1988-09-15
K870722 — LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINENational Medical Care, Medical Products Div., Inc.·Product code FJK·1988-09-14
K881478 — MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORSKeymed (Medical & Industrial Equipment), Ltd.·Product code KNQ·1988-09-14
K881697 — BREAST LESION LOCALIZATION NEEDLEBd Becton Dickinson Vacutainer Systems Preanalytic·Product code IZH·1988-09-14
K882052 — OMEGA NV(TM) BALLOON DILATATION CATHETERCook, Inc.·Product code LIT·1988-09-14
K882311 — SHIMADZU LATERAL C-ARM MH-31Shimadzu Precision Instruments, Inc.·Product code JAA·1988-09-14
K882394 — MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716Medtronic Vascular·Product code CAZ·1988-09-14
K882557 — COULTER CLONE B1 MONOCLONAL ANTIBODYCoulter Immunology·Product code GKZ·1988-09-14
K883072 — DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEMSiemens Gammasonics, Inc.·Product code IZI·1988-09-14
K883087 — PROLOG MP 658M PULSE GENERATORPacesetter Systems·Product code DXY·1988-09-14
K883434 — AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)Ambu, Inc.·Product code BTM·1988-09-14
K883622 — INSTRUMENTARIUM ULF MR IMAGING SYSTEMInstrumentarium Corp.·Product code LNH·1988-09-14
K875280 — STERIS SYSTEM 1 PROCESSOR AND 20 STERILANTSteris C/O Medical Device Consultants, Inc.·Product code MED·1988-09-13
K882089 — MRM GASTROSTOMY BELTMrm Products, Inc.·Product code KNT·1988-09-13
K882218 — COMPAT (R) ENTERAL DELIVERY SYSTEMSandoz Nutrition·Product code KNT·1988-09-13
K882295 — FILLING VOLUME OPTIONEris Medical Technology·Product code LJH·1988-09-13
K882689 — PUNCH MYRINGOTOMY SYSTEMXomed, Inc.·Product code ETD·1988-09-13
K883195 — FRESENIUS F8 DIALYZERFresenius USA, Inc.·Product code KDI·1988-09-13
K883209 — TECHNICON RA-100(TM) SYSTEMTechnicon Instruments Corp.·Product code JJE·1988-09-13
K883247 — LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROLQuantimetrix Medical Industries·Product code JJY·1988-09-13
K883269 — PRL-QUANTLeeco Diagnostics, Inc.·Product code CFT·1988-09-13
K883302 — EMAX PRECISION MICROPLATE READERMolecular Devices Corp.·Product code JJQ·1988-09-13
K883342 — VENTREX COATED TUBE TSHVentrex Laboratories, Inc.·Product code JLW·1988-09-13
K883353 — IQ HDL CHOLESTEROLBd Becton Dickinson Vacutainer Systems Preanalytic·Product code LBR·1988-09-13
K883396 — HANDSWITCHING MONOPOLAR PENCILNew England Surgical Instrument Corp.·Product code GEI·1988-09-13
K883404 — URIC ACID REAGENT (PRODUCT #88219)Hichem Diagnostics·Product code KNK·1988-09-13
K883405 — TRIGLYCERIDES REAGENT (PRODUCT #88218)Hichem Diagnostics·Product code CDT·1988-09-13
K883428 — BIOTROL URIC ACID ENZYMATIQUE TRINDERBiotrol, USA, Inc.·Product code KNK·1988-09-13
K883441 — VISION(R) PROTHROMBIN TIMEAbbott Laboratories·Product code GJS·1988-09-13
K883474 — THORACIC CATHETERSWestmark, Sterile Packing Systems, Inc. (Sps)·Product code GBX·1988-09-13
K883485 — STRYKER PRESSURE MONITOR SYSTEMStryker Corp.·Product code FTY·1988-09-13
K883504 — DURAZYME(R) CPKAmerican Monitor Corp.·Product code CGS·1988-09-13
K883578 — S 21 INSTRUMENT STANDCarl Zeiss, Inc.·Product code FSH·1988-09-13
K883581 — OPMI CSCarl Zeiss, Inc.·Product code EPT·1988-09-13
K883671 — 805 POWER CHAIR CONVERSION SYSTEMRolcontrol Products, Co., Inc.·Product code ITI·1988-09-13
K883672 — PARALYZED VETERANS OF AMERICA POWER RECLINERRolcontrol Products, Co., Inc.·Product code ITI·1988-09-13
K883673 — POWER MECHANICAL RECLINERRolcontrol Products, Co., Inc.·Product code ITI·1988-09-13
K883674 — MANUAL SWING ARMRolcontrol Products, Co., Inc.·Product code ITI·1988-09-13
K883678 — 4007 MODEL RECLINER CONTROLLERRolcontrol Products, Co., Inc.·Product code ITI·1988-09-13
K883679 — WHEELS-OFF QUICK RELEASE AXLE SYSTEMRolcontrol Products, Co., Inc.·Product code KNN·1988-09-13
K880287 — TRU-TRAC COILED GUIDEWIREN-S Medical Products·Product code DQX·1988-09-12
K880288 — TRU-TRAC TORQUE GUIDEWIREN-S Medical Products·Product code DQX·1988-09-12
K881049 — BRADBURY INTRAOCULAR RETINAL KIT CAT #200Microline Pentax, Inc.·Product code HNR·1988-09-12
K881469 — ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNELBaxter Healthcare Corp·Product code FER·1988-09-12
K882474 — OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004Ela Medical, Inc.·Product code DXY·1988-09-12
K882476 — OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004Ela Medical, Inc.·Product code DXY·1988-09-12
K882762 — COLLAGEN SHIELDChiron Ophthalmics·Product code MOE·1988-09-12
K882879 — PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER)Pioneering Technologies, Inc.·Product code DXC·1988-09-12
K883095 — MX860, REUSABLE PRESSURE TRANSDUCERMedex, Inc.·Product code DRS·1988-09-12
K883254 — MULTINEX MONITOR (MODIFICATION)Datascope Corp.·Product code CCL·1988-09-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.